Salt Lake City, UT -- (ReleaseWire) -- 12/02/2020 --As part of a national movement to develop treatments and therapies for COVID-19, Intermountain Healthcare researchers are launching a study in Utah to examine the effects of anticoagulants on patients who have tested positive for the novel coronavirus.
COVID patients in Utah will be among the first patients in the world enrolled in the study, which is unique as it is one of the first and largest studies focusing on treatments options for patients in the community who have not been hospitalized for the virus.
Intermountain is one of three active sites in the United States participating in the national trial, which is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), and is part of Operation Warp Speed, a nationwide public-private partnership examining therapeutics and diagnostics for the COVID-19.
Intermountain researchers are specifically seeking to determine whether a dose of either aspirin or the anticoagulant, apixaban, will prevent the formation of potentially deadly blood clots in patients who are COVID-positive but are not sick enough to be hospitalized.
"This study is looking to see if patients who are less critically-ill from COVID benefit from taking very common medications to prevent the development of blood clots. We want to know if these medications help them from getting worse avoiding hospitalization and death," said Joseph Bledsoe MD, director of research in the department of emergency medicine at Intermountain Healthcare.
Dr. Bledsoe serves on the ACTIV4b protocol development committee and national steering committee for the trial.
While the COVID-19 virus is still new, it has been associated with an increase in the development of blood clots in the legs, lungs, and heart, according to Sarah Majercik, MD, a trauma surgeon and primary investigator of the study at Intermountain Healthcare.
Researchers believe coronavirus may cause microthrombi, or tiny clots, in some COVID-19 patients. When these microthrombi are present in the lungs, this could be the reason why some patients who test positive for the virus may develop severe acute respiratory syndrome.
"These are tiny clots that we can't detect by traditional imaging methods but when in the lungs they may cause patients who are first seem stable to get much sicker quickly, have breathing difficulties, and potentially need a ventilator" said Dr. Sarah Majercik, trauma surgeon at Intermountain Healthcare and principal investigator of the Utah study. "Our aim in this study is to see if these drugs can stop clots from forming so patients who are not hospitalized never fall into this severe category of disease."
For the study, Intermountain researchers are seeking patients between the ages of 40 and 80 who have tested positive for COVID-19 but are not sick enough to need hospital care. They must have normal kidney function and need to meet some other laboratory criteria.
Patients who qualify and are enrolled in the study are given one of four types and doses of medication:
- 81 mg of aspirin taken once a day (a "baby" or low dose aspirin)
- 2.5mg of apixaban taken twice a day
- 5mg of apixaban taken twice a day
- placebo
Patients will take their assigned medication for 45 days, with researchers calling them weekly over a span of 75 days. Researchers will be tracking blood clots, hospitalization, mortality rates, as well as bleeding complications over that same period of time.
People interested in enrolling in the study or want more information, should email Intermountain clinical investigators at COVIDOutpatientTrials@imail.org.
These medications were selected because they have already been proven safe and effective and are commonly used to prevent and treat blood clots in millions of patients every day, according to Dr. Bledsoe.
"Aspirin is routinely prescribed as an anti-inflammatory and blood thinner, and Apixaban is a common anticoagulant that is used after hip and knee surgery and for patients with irregular heart rhythms to prevent blood clots. It has a low-risk of causing excessive bleeding, which can be associated with these types of medications," said Dr. Bledsoe.
Intermountain researchers hope to enroll several hundred patients in the study, which will run through March 2021. Overall, the NHLBI hopes to enroll 7,000 patients across the country.
About Intermountain Healthcare
Intermountain Healthcare is a not-for-profit system of 24 hospitals, 215 clinics, a Medical Group with 2,500 employed physicians and advanced practice clinicians, a health insurance company called SelectHealth, and other health services in Idaho, Utah, and Nevada. Intermountain is widely recognized as a leader in transforming healthcare by using evidence-based best practices to consistently deliver high-quality outcomes and sustainable costs. For more information, see intermountainhealthcare.org.